Staff Microbiologist

Stryker; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker in San Jose, CA, is seeking a Staff Microbiologist to provide technical expertise across development, validation, and lifecycle management of medical devices within the Endoscopy business unit.

You will lead cross-functional microbiology, biocompatibility, sterilization, and reprocessing activities, author/approve technical docs, and support regulatory submissions to ensure biological safety and compliance throughout the product lifecycle.

Qualifications

• Bachelor's degree in biology, microbiology, biomedical engineering, toxicology, or related field.
• Minimum 4 years in regulated healthcare environments supporting microbiology, biocompatibility, sterilization or related activities.
• Working knowledge of ISO 10993, ISO 11135, ISO 11137, ISO 17665, AAMI, FDA, EU MDR or equivalent.
• Experience authoring and reviewing BEP/BER, test plans and validation documents.

Responsibilities

• Develop microbiology, biocompatibility, sterilization, and reprocessing test strategies for medical devices.
• Lead microbiology and biocompatibility activities for development projects.
• Collaborate with R&D on materials, design, sterilization methods, and reprocessing considerations.
• Prepare protocols, reports, risk assessments, and regulatory documentation.
• Support design reviews, milestones, engineering changes, supplier changes, CAPAs, and regulatory submissions.
• Execute sterilization process validations and IQ/OQ/PQ activities.
• Assess risks and drive solutions to ensure safety and compliance.
• Participate in regulatory and supplier audits as SME for microbiology and sterilization.
• Contribute to procedures, work instructions, and process improvements.
• Collaborate with R&D, Regulatory Affairs, Quality, Manufacturing, and external labs.

Skills

Microbiology expertise

Regulatory readiness

Cross-functional collaboration

Technical leadership

Education

Bachelor's degree in biology, microbiology, biomedical engineering, toxicology, or related field

Job description

Stryker is seeking a Staff Microbiologist for our Endoscopy business unit in San Jose, CA. We are seeking a talented and motivated Microbiologist to provide technical expertise supporting the development, validation, and lifecycle management of medical devices. In this role, you will partner with cross-functional teams to support microbiology, sterilization, reprocessing, and biocompatibility activities for both new product development and sustaining engineering efforts. You will independently lead assigned projects, develop technical strategies, and ensure products meet applicable biological safety, sterilization, and regulatory requirements. This position plays a key role in supporting product quality, regulatory compliance, and patient safety through the application of scientific principles, industry standards, and risk-based decision making throughout the product lifecycle.

What You Will Do

• Apply ISO, FDA, AAMI, EU MDR, and other applicable standards to develop microbiology, biocompatibility, sterilization, and reprocessing test strategies for medical devices.
• Lead microbiology and biocompatibility activities for product development projects, including defining testing requirements, acceptance criteria, and validation strategies.
• Partner with R&D teams to provide technical guidance on materials, product design, sterilization methods, and reprocessing considerations throughout development.
• Develop, review, and approve protocols, reports, risk assessments, and technical documentation supporting biological safety, sterilization, processing, and regulatory compliance.
• Support design reviews, development milestones, engineering changes, supplier changes, nonconformance investigations, CAPAs, and regulatory submissions.
• Execute and support sterilization process validations, equipment qualifications (IQ/OQ/PQ), requalification activities, and microbiological monitoring programs.
• Assess technical risks and recommend solutions to ensure product safety, performance, compliance, and successful project execution.
• Participate in regulatory and supplier audits as a subject matter expert for microbiology, sterilization, biocompatibility, and reprocessing activities.
• Contribute to the development and continuous improvement of procedures, work instructions, and processes to align with evolving regulations and industry standards.
• Support knowledge sharing and onboarding activities by providing technical guidance and training to team members and cross-functional partners.
• Collaborate with cross-functional teams including R&D, Regulatory Affairs, Quality, Manufacturing, Operations, and external testing laboratories.

What You Need

Required Qualifications

• Bachelor's degree in biology, Microbiology, Biomedical Engineering, Toxicology, or a related scientific discipline.
• Minimum 4 years of experience in medical device, pharmaceutical, biotechnology, or regulated healthcare environments supporting microbiology, biocompatibility, sterilization, processing, or sterility assurance activities for sterile and/or reusable products.
• Working knowledge of medical device regulations such as ISO 10993, ISO 11135, ISO 11137, ISO 17665, AAMI, FDA, EU MDR, and other applicable regulatory standards.
• Experience authoring and reviewing technical documentation, including biological evaluation plans/reports (BEP/BER), test plans, validation protocols, validation documentation, and technical reports.

Preferred Qualifications

• Master's degree or Ph.D. in Biology, Microbiology, Biomedical Engineering, Toxicology, Chemistry, or a related scientific discipline.
• Experience spanning all three key technical disciplines: reusable medical device processing validations, terminal sterilization technologies, and biological testing strategy development and biological safety evaluations.
• Experience working with external test laboratories, contract sterilizers, and suppliers supporting biological safety or sterilization activities.
• Experience supporting regulatory submissions for global markets.

United States of America Pay Ranges

• Puerto Rico: $77,700 - $129,500 USD Annual
• USN: $83,300 - $138,800 USD Annual
• US5: $87,500 - $145,700 USD Annual
• US10: $91,600 - $152,700 USD Annual
• US15: $95,800 - $159,600 USD Annual
• US20: $100,000 - $166,600 USD Annual
• US30: $108,300 - $180,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.